VB119 for Focal Segmental Glomerulosclerosis

Recruiting at 8 trial locations
PD
Overseen ByProject Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Tenet Medicines
Must be taking: Prednisone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called VB119 to see if it can help keep certain kidney diseases under control. It focuses on adults with specific kidney conditions (MCD or FSGS) who have shown improvement with previous treatments. The goal is to see if VB119 can maintain their improvement and make it last longer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of prednisone (a type of steroid) of no more than 20 mg/day for at least 14 days before starting the trial.

Research Team

K

Keenan

Principal Investigator

ValenzaBio, Inc.

Eligibility Criteria

Adults over 18 with a kidney biopsy-proven diagnosis of primary MCD or FSGS within the last 10-20 years, who responded to steroids before and have had significant proteinuria in the past 2 years. Participants must be on a stable prednisone dose and have controlled blood pressure. Women must be non-childbearing or use contraception; men agree not to donate sperm for 4 months post-trial.

Inclusion Criteria

My kidney condition improved completely after using steroids.
I agree not to donate sperm for 125 days after my last dose of the study drug.
I am on prednisone, expected to reduce to ≤20 mg/day for 2 weeks before starting.
See 7 more

Exclusion Criteria

Has an absolute neutrophil count <1.5 x 10/L
I have an ongoing infection, such as TB, hepatitis, HIV, or a UTI.
I have type 1 or type 2 diabetes.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VB119 100 or 200mg IV doses administered 4 times

39 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

  • VB119
Trial OverviewThe trial is testing VB119's effectiveness in maintaining remission and prolonging response duration in adults with primary MCD or FSGS who previously responded to steroid therapy. It's a Phase 2 study across multiple centers, focusing on those who've seen benefits from steroids.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VB119Experimental Treatment1 Intervention
VB119 100 or 200mg IV doses administered 4 times

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tenet Medicines

Lead Sponsor

Trials
3
Recruited
7+

ValenzaBio, Inc.

Lead Sponsor

Trials
3
Recruited
60+

ACELYRIN Inc.

Lead Sponsor

Trials
9
Recruited
1,100+